83 FR 6196 - Proposal To Refuse To Approve a New Drug Application for Oxycodone Hydrochloride Immediate-Release Oral Capsules, 5 Milligrams, 15 Milligrams, and 30 Milligrams; Opportunity for a Hearing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 30 (February 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 30 (February 13, 2018)
| Page Range | 6196-6198 | |
| FR Document | 2018-02903 |
[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)] [Notices] [Pages 6196-6198] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02903] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0188] Proposal To Refuse To Approve a New Drug Application for Oxycodone Hydrochloride Immediate-Release Oral Capsules, 5 Milligrams, 15 Milligrams, and 30 Milligrams; Opportunity for a Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Director of the Center for Drug Evaluation and Research (Center Director) of the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a new drug application (NDA) submitted by Pharmaceutical Manufacturing Research Services, Inc. (PMRS) for oxycodone hydrochloride (HCl) immediate-release (IR) oral capsules, 5 milligrams (mg), 15 mg, and 30 mg in its present form. This notice summarizes the grounds for the Center Director's proposal and offers PMRS an opportunity to request a hearing on the matter. DATES: Submit either electronic or written requests for a hearing by March 15, 2018; submit data, information, and analyses in support of the hearing and any other comments by April 16, 2018. ADDRESSES: You may submit hearing requests, documents in support of the hearing, and any other comments as follows. Please note that late, untimely filed requests and documents will not be considered. Electronic requests for a hearing must be submitted on or before March 15, 2018; electronic documents in support of the hearing and any other comments must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept hearing requests until midnight Eastern Time at the end of March 15, 2018, and will accept documents in support of the hearing and any other comments until midnight Eastern Time at the end of April 16, 2018. Documents received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before these dates. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-0188, for ``Proposal to Refuse to Approve a New Drug Application for Oxycodone Hydrochloride Immediate-Release Oral Capsules, 5 Milligrams, 15 Milligrams, and 30 Milligrams; Opportunity for a Hearing.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/ [[Page 6197]] fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Patrick Raulerson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6260, Silver Spring, MD, 20993, 301-796- 3522, [email protected]. SUPPLEMENTARY INFORMATION: I. Proposal To Refuse To Approve NDA 209155 PMRS submitted NDA 209155 for oxycodone HCl IR oral capsules in 5 mg, 15 mg, and 30 mg strengths (oxycodone HCl IR capsules) under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(b)(2)), proposing to rely in part on the Agency's previous finding of safety and effectiveness for ROXICODONE (oxycodone HCl) IR Tablets (NDA 021011). PMRS proposed that its oxycodone HCl IR capsules be indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. PMRS also attempted to show that the product had certain abuse-deterrent properties and sought FDA approval of labeling describing those properties. On November 16, 2017, the Division of Anesthesia, Analgesia, and Addiction Products of FDA's Center for Drug Evaluation and Research (CDER) issued a complete response letter to PMRS under Sec. 314.110(a) (21 CFR 314.110(a)) stating that NDA 209155 could not be approved in its present form, describing the specific deficiencies, and, where possible, recommending ways PMRS might remedy these deficiencies. The deficiencies include the following: 1. The application in its present form is not approvable with the proposed labeling describing abuse-deterrent properties, for multiple reasons. In particular, (1) the oxycodone in the formulation can be readily extracted in commonly available solvents into a solution suitable for injection; (2) there were insufficient data showing the presence of excipients (including dye) in the formulation can be expected to deter abuse by injection; (3) the data submitted were insufficient to show the product was meaningfully resistant to manipulation for misuse or abuse; and (4) there were not data submitted, including data from pharmacokinetic and human abuse liability studies, fully characterizing the product's abuse potential by all relevant routes of abuse. Also, the data submitted were not sufficient to rule out the possibility that the proposed formulation could result in a greater proportion of abuse by injection of PMRS's product compared to a conventional IR oxycodone formulation. Abuse by injection carries greater risk of overdose and transmission of infectious disease than abuse by other routes. 2. The safety and purity of the excipients intended (but not shown) to confer abuse deterrent properties were not adequately characterized, either by the intended oral route of use or by expected routes of abuse, including injection. 3. An overall evaluation of elemental impurities in the final formulation and a risk assessment for each heavy metal (taking into consideration the maximum daily dose) were not provided. 4. The application did not fully comply with the patent certification requirements applicable to applications submitted under section 505(b)(2) of the FD&C Act. 5. The complete response letter describes additional deficiencies, which generally relate to chemistry, manufacturing, and controls and current good manufacturing practice requirements, that CDER determined preclude approval of the application in its present form. The complete response letter also noted that satisfactory resolution of objectionable inspection observations was required before the application could be approved. Due to applicable limitations on public disclosure of information contained in unapproved NDAs, including trade secret information, these specific deficiencies are not described in this notice. The complete response letter stated that PMRS is required to resubmit the application, fully addressing all deficiencies listed in the letter, or take other actions available under Sec. 314.110 (i.e., withdraw the application or request an opportunity for a hearing). Applicable regulations, including Sec. 10.75 (21 CFR 10.75), also provide a mechanism for applicants to obtain formal review of one or more decisions reflected in a complete response letter (see FDA's guidance for industry ``Formal Dispute Resolution: Sponsor Appeals Above the Division Level'' (November 2017) available at: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm343101.pdf). In response to the complete response letter, on November 17, 2017, PMRS submitted a request for an opportunity for a hearing under Sec. 314.110(b)(3) on whether there are grounds under section 505(d) of the FD&C Act for denying approval of NDA 209155. II. Notice of Opportunity for a Hearing For the reasons stated previously and others described in the complete response letter, notice is given to PMRS and to all other interested persons that the Center Director proposes to issue an order refusing to approve NDA 209155 on the grounds that the application fails to meet the criteria for approval under section 505(d) of the FD&C Act, including that: (1) PMRS has not provided sufficient data to show that the product would be safe (505(d)(1)); (2) PMRS has not shown that the methods used in, and the facilities and controls used for the manufacture, processing, or packing of the product are adequate to preserve its identity, strength, quality, and purity (505(d)(3)); and (3) the labeling PMRS proposed for the product is false or misleading (505(d)(7)). PMRS may request a hearing before the Commissioner of Food and Drugs (the Commissioner) on the Center Director's proposal to refuse to approve NDA 209155. If PMRS decides to seek a hearing, it must file: (1) A written notice of participation and request for a hearing (see the DATES section), and (2) the studies, data, information, and analyses relied upon to justify a hearing (see the DATES section), as specified in Sec. [thinsp]314.200. As stated in Sec. 314.200(g), a request for a hearing may not rest upon mere allegations or denials, but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing to resolve. We note in this regard that because CDER proposes to refuse to approve NDA 209155 for multiple reasons, any hearing request from PMRS must address all of those reasons, including reasons described in the complete response letter but not described in this notice due to applicable limitations on public disclosure of information contained in unapproved NDAs, including trade secret information. Failure to request a hearing within the time provided and in the manner required by Sec. 314.200 constitutes a waiver of the opportunity to request a hearing. If a hearing request is not properly submitted, FDA will issue a notice refusing to approve NDA 209155. [[Page 6198]] The Commissioner will grant a hearing if there exists a genuine and substantial issue of fact or if the Commissioner concludes that a hearing would otherwise be of public interest (Sec. 314.200(g)(6)). If a hearing is granted, it will be conducted according to the procedures provided in 21 CFR parts 10 through 16 (21 CFR 314.201). Paper submissions under this notice of opportunity for a hearing must be filed in two copies. Except for data and information prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, submissions may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and on the internet at https://www.regulations.gov. This notice is issued under section 505(c)(1)(B) of the FD&C Act, Sec. Sec. 314.110(b)(3) and 314.200. Dated: February 8, 2018. Janet Woodcock, Director, Center for Drug Evaluation and Research. [FR Doc. 2018-02903 Filed 2-12-18; 8:45 am] BILLING CODE 4164-01-P
![6196 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices
information concerning the definition of Pharmaceutical Manufacturing Research manner detailed (see ‘‘Written/Paper
complete response. Services, Inc. (PMRS) for oxycodone Submissions’’ and ‘‘Instructions’’).
This guidance is being issued hydrochloride (HCl) immediate-release
consistent with FDA’s good guidance Written/Paper Submissions
(IR) oral capsules, 5 milligrams (mg), 15
practices regulation (21 CFR 10.115). mg, and 30 mg in its present form. This Submit written/paper submissions as
The guidance represents the current notice summarizes the grounds for the follows:
thinking of FDA on BCG-unresponsive Center Director’s proposal and offers • Mail/Hand delivery/Courier (for
nonmuscle invasive bladder cancer. It PMRS an opportunity to request a written/paper submissions): Dockets
does not establish any rights for any hearing on the matter. Management Staff (HFA–305), Food and
person and is not binding on FDA or the Drug Administration, 5630 Fishers
DATES: Submit either electronic or
public. You can use an alternative Lane, Rm. 1061, Rockville, MD 20852.
written requests for a hearing by March • For written/paper comments
approach if it satisfies the requirements 15, 2018; submit data, information, and
of the applicable statutes and submitted to the Dockets Management
analyses in support of the hearing and Staff, FDA will post your comment, as
regulations. This guidance is not subject any other comments by April 16, 2018.
to Executive Order 12866. well as any attachments, except for
ADDRESSES: You may submit hearing information submitted, marked and
II. The Paperwork Reduction Act of requests, documents in support of the identified, as confidential, if submitted
1995 hearing, and any other comments as as detailed in ‘‘Instructions.’’
This guidance refers to previously follows. Please note that late, untimely Instructions: All submissions received
approved collections of information that filed requests and documents will not must include the Docket No. FDA–
are subject to review by the Office of be considered. Electronic requests for a 2018–N–0188, for ‘‘Proposal to Refuse to
Management and Budget (OMB) under hearing must be submitted on or before Approve a New Drug Application for
the Paperwork Reduction Act of 1995 March 15, 2018; electronic documents Oxycodone Hydrochloride Immediate-
(44 U.S.C. 3501–3520). The collections in support of the hearing and any other Release Oral Capsules, 5 Milligrams, 15
of information in 21 CFR parts 312 and comments must be submitted on or Milligrams, and 30 Milligrams;
314 have been approved under OMB before April 16, 2018. The https:// Opportunity for a Hearing.’’ Received
control numbers 0910–0014 and 0910– www.regulations.gov electronic filing comments, those filed in a timely
0001, respectively. system will accept hearing requests manner (see ADDRESSES), will be placed
until midnight Eastern Time at the end in the docket and, except for those
III. Electronic Access of March 15, 2018, and will accept submitted as ‘‘Confidential
Persons with access to the internet documents in support of the hearing Submissions,’’ publicly viewable at
may obtain the guidance at either and any other comments until midnight https://www.regulations.gov or at the
https://www.fda.gov/Drugs/Guidance Eastern Time at the end of April 16, Dockets Management Staff between 9
ComplianceRegulatoryInformation/ 2018. Documents received by mail/hand a.m. and 4 p.m., Monday through
Guidances/default.htm, https:// delivery/courier (for written/paper Friday.
www.fda.gov/BiologicsBloodVaccines/ submissions) will be considered timely • Confidential Submissions—To
GuidanceComplianceRegulatory if they are postmarked or the delivery submit a comment with confidential
Information/default.htm, or https:// service acceptance receipt is on or information that you do not wish to be
www.regulations.gov. before these dates. made publicly available, submit your
comments only as a written/paper
Dated: February 7, 2018. Electronic Submissions submission. You should submit two
Leslie Kux, Submit electronic comments in the copies total. One copy will include the
Associate Commissioner for Policy. following way: information you claim to be confidential
[FR Doc. 2018–02871 Filed 2–12–18; 8:45 am] • Federal eRulemaking Portal: with a heading or cover note that states
BILLING CODE 4164–01–P https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
Comments submitted electronically, Agency will review this copy, including
DEPARTMENT OF HEALTH AND including attachments, to https:// the claimed confidential information, in
HUMAN SERVICES www.regulations.gov will be posted to its consideration of comments. The
the docket unchanged. Because your second copy, which will have the
Food and Drug Administration
comment will be made public, you are claimed confidential information
[Docket No. FDA–2018–N–0188] solely responsible for ensuring that your redacted/blacked out, will be available
comment does not include any for public viewing and posted on
Proposal To Refuse To Approve a New confidential information that you or a https://www.regulations.gov. Submit
Drug Application for Oxycodone third party may not wish to be posted, both copies to the Dockets Management
Hydrochloride Immediate-Release Oral such as medical information, your or Staff. If you do not wish your name and
Capsules, 5 Milligrams, 15 Milligrams, anyone else’s Social Security number, or contact information to be made publicly
and 30 Milligrams; Opportunity for a confidential business information, such available, you can provide this
Hearing as a manufacturing process. Please note information on the cover sheet and not
AGENCY: Food and Drug Administration, that if you include your name, contact in the body of your comments and you
HHS. information, or other information that must identify this information as
identifies you in the body of your ‘‘confidential.’’ Any information marked
sradovich on DSK3GMQ082PROD with NOTICES
ACTION: Notice.
comments, that information will be as ‘‘confidential’’ will not be disclosed
SUMMARY: The Director of the Center for posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
Drug Evaluation and Research (Center • If you want to submit a comment and other applicable disclosure law. For
Director) of the Food and Drug with confidential information that you more information about FDA’s posting
Administration (FDA or Agency) is do not wish to be made available to the of comments to public dockets, see 80
proposing to refuse to approve a new public, submit the comment as a FR 56469, September 18, 2015, or access
drug application (NDA) submitted by written/paper submission and in the the information at: https://www.gpo.gov/
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![6198 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices
The Commissioner will grant a during the regulatory review period by 2015–E–2666; FDA–2015–E–2758; and
hearing if there exists a genuine and August 13, 2018. See ‘‘Petitions’’ in the FDA–2015–E–2664 for ‘‘Determination
substantial issue of fact or if the SUPPLEMENTARY INFORMATION section for of Regulatory Review Period for
Commissioner concludes that a hearing more information. Purposes of Patent Extension;
would otherwise be of public interest ADDRESSES: You may submit comments FARYDAK.’’ Received comments, those
(§ 314.200(g)(6)). If a hearing is granted, as follows. Please note that late, filed in a timely manner (see
it will be conducted according to the untimely filed comments will not be ADDRESSES), will be placed in the
procedures provided in 21 CFR parts 10 considered. Electronic comments must dockets and, except for those submitted
through 16 (21 CFR 314.201). be submitted on or before April 16, as ‘‘Confidential Submissions,’’ publicly
Paper submissions under this notice 2018. The https://www.regulations.gov viewable at https://www.regulations.gov
of opportunity for a hearing must be electronic filing system will accept or at the Dockets Management Staff
filed in two copies. Except for data and comments until midnight Eastern Time between 9 a.m. and 4 p.m., Monday
information prohibited from public at the end of April 16, 2018. Comments through Friday.
disclosure under 21 U.S.C. 331(j) or 18 received by mail/hand delivery/courier • Confidential Submissions—To
U.S.C. 1905, submissions may be seen (for written/paper submissions) will be submit a comment with confidential
in the Dockets Management Staff considered timely if they are information that you do not wish to be
between 9 a.m. and 4 p.m., Monday postmarked or the delivery service made publicly available, submit your
through Friday, and on the internet at acceptance receipt is on or before that comments only as a written/paper
https://www.regulations.gov. This notice date. submission. You should submit two
is issued under section 505(c)(1)(B) of copies total. One copy will include the
Electronic Submissions
the FD&C Act, §§ 314.110(b)(3) and information you claim to be confidential
314.200. Submit electronic comments in the with a heading or cover note that states
following way: ‘‘THIS DOCUMENT CONTAINS
Dated: February 8, 2018.
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Janet Woodcock, https://www.regulations.gov. Follow the Agency will review this copy, including
Director, Center for Drug Evaluation and instructions for submitting comments.
Research.
the claimed confidential information, in
Comments submitted electronically, its consideration of comments. The
[FR Doc. 2018–02903 Filed 2–12–18; 8:45 am] including attachments, to https:// second copy, which will have the
BILLING CODE 4164–01–P www.regulations.gov will be posted to claimed confidential information
the docket unchanged. Because your redacted/blacked out, will be available
comment will be made public, you are for public viewing and posted on
DEPARTMENT OF HEALTH AND solely responsible for ensuring that your https://www.regulations.gov. Submit
HUMAN SERVICES comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
Food and Drug Administration
third party may not wish to be posted, contact information to be made publicly
[Docket Nos. FDA–2015–E–2666; FDA– such as medical information, your or available, you can provide this
2015–E–2758; and FDA–2015–E–2664] anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
Determination of Regulatory Review as a manufacturing process. Please note
Period for Purposes of Patent must identify this information as
that if you include your name, contact ‘‘confidential.’’ Any information marked
Extension; FARYDAK information, or other information that as ‘‘confidential’’ will not be disclosed
AGENCY: Food and Drug Administration, identifies you in the body of your except in accordance with § 10.20 (21
HHS. comments, that information will be CFR 10.20) and other applicable
ACTION: Notice. posted on https://www.regulations.gov. disclosure law. For more information
• If you want to submit a comment about FDA’s posting of comments to
SUMMARY: The Food and Drug with confidential information that you public dockets, see 80 FR 56469,
Administration (FDA or the Agency) has do not wish to be made available to the September 18, 2015, or access the
determined the regulatory review period public, submit the comment as a information at: https://www.gpo.gov/
for FARYDAK and is publishing this written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
notice of that determination as required manner detailed (see ‘‘Written/Paper 23389.pdf.
by law. FDA has made the Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
determination because of the Written/Paper Submissions read background documents or the
submission of applications to the electronic and written/paper comments
Director of the U.S. Patent and Submit written/paper submissions as
received, go to https://
Trademark Office (USPTO), Department follows:
www.regulations.gov and insert the
• Mail/Hand Delivery/Courier (for
of Commerce, for the extension of a docket number, found in brackets in the
written/paper submissions): Dockets
patent which claims that human drug heading of this document, into the
Management Staff (HFA–305), Food and
product. ‘‘Search’’ box and follow the prompts
Drug Administration, 5630 Fishers
DATES: Anyone with knowledge that any and/or go to the Dockets Management
Lane, Rm. 1061, Rockville, MD 20852.
of the dates as published (in the • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
SUPPLEMENTARY INFORMATION section) are Rockville, MD 20852.
sradovich on DSK3GMQ082PROD with NOTICES
submitted to the Dockets Management
incorrect may submit either electronic Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT:
or written comments and ask for a well as any attachments, except for Beverly Friedman, Office of Regulatory
redetermination by April 16, 2018. information submitted, marked and Policy, Food and Drug Administration,
Furthermore, any interested person may identified, as confidential, if submitted 10903 New Hampshire Ave., Bldg. 51,
petition FDA for a determination as detailed in ‘‘Instructions.’’ Rm. 6250, Silver Spring, MD 20993,
regarding whether the applicant for Instructions: All submissions received 301–796–3600.
extension acted with due diligence must include the Docket Nos. FDA– SUPPLEMENTARY INFORMATION:
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Document Created: 2018-02-13 02:32:20
Document Modified: 2018-02-13 02:32:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written requests for a hearing by March 15, 2018; submit data, information, and analyses in support of the hearing and any other comments by April 16, 2018. | |
| Contact | Patrick Raulerson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6260, Silver Spring, MD, 20993, 301-796- 3522, [email protected] | |
| FR Citation | 83 FR 6196 |
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